Open Needle Guide LNGO-2022

GUDID 10813079020421

20/22ga (0.9/0.7mm)

REMINGTON MEDICAL, INC.

Nonimplantable needle guide, single-use
Primary Device ID10813079020421
NIH Device Record Key520fc6a5-116d-4ce6-885f-ac6c16f9c1c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpen Needle Guide
Version Model NumberLNGO-2022
Catalog NumberLNGO-2022
Company DUNS788472314
Company NameREMINGTON MEDICAL, INC.
Device Count2
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com

Device Dimensions

Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100813079020424 [Primary]
GS110813079020421 [Package]
Contains: 00813079020424
Package: Inner Carton [10 Units]
In Commercial Distribution
GS120813079020428 [Package]
Package: Shipping Carton [10 Units]
In Commercial Distribution
GS180813079020420 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZHSystem, x-ray, mammographic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

[10813079020421]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-02
Device Publish Date2020-09-24

Devices Manufactured by REMINGTON MEDICAL, INC.

10813079022616 - VascuChek Surgical Probe2024-09-02 Surgical Probe (sterile) used with transceiver
00813079022626 - VascuChek Transceiver2024-09-02 Hand-held, battery operated transceiver used to monitor blood flow.
00813079022633 - VascuChek Charger2024-09-02 Replacement Charger used with the transceiver
00813079022640 - VascuChek Kit2024-09-02 Kit that contains 1 transceiver, 1 clinical probe, 1 charger, and 1 pack of ultrasound gel
10813079022654 - VascuChek Clinical Probe2024-09-02 Clinical Probe (non-sterile) used with transceiver.
10813079020223 - Bone Marrow "I" Needle2020-10-02 15ga (1.8mm) x 1 7/8" (5cm)
20813079020237 - Bone Marrow "I" Needle2020-10-02 16ga (1.7mm) x 1 7/8" (5cm)
10813079020247 - Bone Marrow "J" Needle Double Diamond Tip2020-10-02 11ga (3.0mm) x 4in. (10cm)
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